Effectiveness and Safety of Risankizumab in Crohn Disease After Failure of a First Line of Advanced Therapy: A Long-Term, Real-Life Study

BACKGROUND: Risankizumab (RZB) is an anti-interleukin 23 (anti-IL-23) approved for the treatment of Crohn disease (CD). STUDY QUESTION: We aimed to evaluate the effectiveness and safety of RZB in the treatment of CD in real-world settings. STUDY DESIGN: We performed a retrospective review of a multicentre consortium of patients with CD treated with RZB. MEASURES AND OUTCOMES: Coprimary outcomes were clinical remission at week 12, 24, and 52 (Harvey-Bradshaw Index score of ≤4), and safety. Secondary outcomes included steroid-free clinical remission, clinical response, and endoscopic remission at 52 weeks. RESULTS: A total of 487 patients were included. The median follow-up was 24 (interquartile range: 16-38) weeks. A total of 372 (76.4%) patients achieved clinical remission at maximal follow-up. According to the treatment line in which RZB was administered, clinical remission occurred in 115/134 (85.8%) patients on second-line therapy, 112/153 (73.2%) on third-line therapy, and 145/200 (72.5%) on fourth-line therapy, with a significant difference (P = 0.010). Adverse events occurred in 60 patients (12.6%) during follow-up; most of them were mild (50/60, 83.3%). Regarding the secondary outcomes: steroid-free clinical remission was achieved in 342 (71.8%) patients, and clinical response was observed in 443 (91.0%) patients. Six (1.2%) patients underwent surgery during follow-up. Mucosal healing was achieved in 34/67 (50.7%) patients. CONCLUSIONS: In this extensive, real-world study, RZB was effective and well tolerated in an advanced-therapy-exposed population of patients with CD and associated with favorable clinical and endoscopic outcomes.

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Publication Details

Journal
American Journal of Therapeutics
Published
2026-07-23
DOI
https://doi.org/10.1097/mjt.0000000000002171
Primary Topic
Inflammatory Bowel Disease
Type
article
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article

Effectiveness and Safety of Risankizumab in Crohn Disease After Failure of a First Line of Advanced Therapy: A Long-Term, Real-Life Study

Rita Monterubbianesi, Fabio Cortellini, P. Capone, Domenico Catarella et al.
American Journal of Therapeutics
Inflammatory Bowel Disease
article

Effectiveness and Safety of Risankizumab in Crohn Disease After Failure of a First Line of Advanced Therapy: A Long-Term, Real-Life Study

Rita Monterubbianesi, Fabio Cortellini, P. Capone, Domenico Catarella, Raffaele Pellegrino, Laura Bolognini, L. Donnarumma, Patrizio Scarozza, Mario Erboso, Antonio Tursi, Marta Patturelli, Nicola Della Valle, Michela Di Fonzo, Elena Del Zanna, Francesco Bachetti, Dario D’Agostino, Costantino Zampaletta, M. Rizzi, Francesco Martini, A. Scarcelli, Paolo Tonti, Federica Gaiani, A. Pasta, Stefano Rodinò, Agnese Miranda, Caterina Mucherino, Giulia Zerboni, E D'Antonio, Maurizio Giovannone, Ladislava Sebkova, Giuseppina Vincoli, Ileana Luppino, Giovanni Aragona, Laura Montesano, Davide Checchin, Giovanni Cataletti, Giuseppe Pranzo, Marcello Picchio, Marina Rizzi, Elisa Stasi, Giulia Rocco, Viviana Neve, Francesca Lamboglia, Giammarco Mocci, Giorgia Bodini, Claudia Quatraccioni, Silvia Sedda, Walter Elisei, Carlotta Sacchi, Francesca Maria Onidi, C. Cassieri, A. Bucci, Giacomo Forti, Simona Piergallini, Lorenzo Bertani, Davide Giuseppe Ribaldone, Patrizia Perazzo, Federico Iacopini, Berardino D’Ascoli, Manuela Marzo, Giuliana Vespere, Andrea Cocco, Antonio Cuomo, Raffaele Colucci, Gianluigi De Angelis, C.M. Palmisano, Serafina Fiorella, Laurino Grossi, Linda Ceccarelli, Domenico Morano, Elisabetta Antonelli, Alessandro Gigliozzi, Mariaelena Serio, C De Barba, Daniele Balducci, Cristiano Pagnini, Antonietta G. Gravina, Libera Fanigliulo, Girolamo Bevevino, L De Luca, G Lombardi, M Montori, E Bendia, Alessandro Massari, Francesco Ferrara, Rocco Spagnuolo, Giovanni Maconi, Roberta Pica, Edoardo V. Savarino, Francesco Luzza, Leonardo Allegretta, Elisabetta D. I. Bartolo, Franco Scaldaferri, Francesco Gatti, Antonio Grandolfo, Francesco Costa, Eleonora Schillaci, Daniele Napolitano, Gabrio Bassotti, Paolo Usai Satta
article en

Abstract

BACKGROUND: Risankizumab (RZB) is an anti-interleukin 23 (anti-IL-23) approved for the treatment of Crohn disease (CD). STUDY QUESTION: We aimed to evaluate the effectiveness and safety of RZB in the treatment of CD in real-world settings. STUDY DESIGN: We performed a retrospective review of a multicentre consortium of patients with CD treated with RZB. MEASURES AND OUTCOMES: Coprimary outcomes were clinical remission at week 12, 24, and 52 (Harvey-Bradshaw Index score of ≤4), and safety. Secondary outcomes included steroid-free clinical remission, clinical response, and endoscopic remission at 52 weeks. RESULTS: A total of 487 patients were included. The median follow-up was 24 (interquartile range: 16-38) weeks. A total of 372 (76.4%) patients achieved clinical remission at maximal follow-up. According to the treatment line in which RZB was administered, clinical remission occurred in 115/134 (85.8%) patients on second-line therapy, 112/153 (73.2%) on third-line therapy, and 145/200 (72.5%) on fourth-line therapy, with a significant difference (P = 0.010). Adverse events occurred in 60 patients (12.6%) during follow-up; most of them were mild (50/60, 83.3%). Regarding the secondary outcomes: steroid-free clinical remission was achieved in 342 (71.8%) patients, and clinical response was observed in 443 (91.0%) patients. Six (1.2%) patients underwent surgery during follow-up. Mucosal healing was achieved in 34/67 (50.7%) patients. CONCLUSIONS: In this extensive, real-world study, RZB was effective and well tolerated in an advanced-therapy-exposed population of patients with CD and associated with favorable clinical and endoscopic outcomes.

American Journal of Therapeutics
Università Cattolica del Sacro Cuore (IT), University of Parma (IT), University of Padua (IT), University of Campania "Luigi Vanvitelli" (IT), University of Perugia (IT), Azienda Ospedaliera San Giovanni Addolorata (IT), Policlinico Umberto I (IT), Martin University (US), CTO Hospital (IT), Agostino Gemelli University Polyclinic (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Antonio Cardarelli (IT), Luigi Sacco Hospital (IT), Ospedali Riuniti di Foggia (IT), Ellis Hospital (US), San Salvatore Hospital (IT), Ospedale di Spoleto (IT), Ospedale A. Perrino (IT), Ospedale Garibaldi (IT), Ospedale Sant'Anna (IT), Ospedale di Santo Spirito (IT), Azienda Ospedaliero Universitaria Ospedali Riuniti (IT), Department of Medical Sciences (RU), Ospedale San Paolo (IT), CTO Andrea Alesini (IT), Ospedale Veris Delli Ponti Scorrano (IT), Ospedale Madonna Delle Grazie (IT), Imamura Hospital (JP), Ospedale di Belcolle (IT), Ospedale Infermi di Rimini (IT), IRCCS San Camillo Hospital (IT), Ospedale Annunziata di Cosenza (IT), Ospedale L. Bonomo (IT), Guglielmo da Saliceto Hospital (IT), Ospedale Martini (IT), Ospedale Santa Maria Goretti (IT), Ospedale Monaldi (IT), Ospedale Policlinico San Martino (IT), Azienda Ospedaliera Pugliese Ciaccio (IT), Ospedale Sant'Anna (IT), Ospedale D. Cotugno (IT), Ospedale SS. Annunziata (IT), Ospedale Vito Fazzi (IT), Ospedale Eugenio Morelli (IT), Azienda Usl Toscana Centro (IT), Azienda Sanitaria Locale Roma 3 (IT), Ospedale Civile di Venezia (IT), Azienda Ospedaliera G. Brotzu (IT)
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Inflammatory Bowel Disease
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